反相高压液相色谱法测定亚叶酸钙制剂的含量及其稳定性考察

Determination of calcium folinate by reverse phase high performance liquid chromatography and stability inspection of its preparation

目的 :建立反相高压液相色谱法测定亚叶酸钙片剂和胶囊含量的方法 ,同时检查其有关物质 ,并进行稳定性考察。方法 :采用LichrosorbC18色谱柱 ,以乙腈∶1 0mmol·L-1醋酸钠 三乙胺缓冲液 (冰醋酸调 pH至 5 .5 ) (4∶96)为流动相 ,流速 1 .2mL·min-1;检测波长 2 86nm ,柱温为常温。结果 :在色谱条件下 ,亚叶酸钙制剂的分析不受辅料和降解产物的干扰 ,其检测限为 0 .0 4μg ,定量限为 0 .1 2 μg ,在 1 2 .5～ 1 5 0mg·L-1范围内线性关系良好 (r =0 .9998) ,加样回收率为 99%～ 1 0 1 % ,日内、日间RSD <3 .0 %。结论 :本法灵敏准确 ,方便实用。

AIM: To develop a RP HPLC method for the determination of calcium folinate and its related substances in tablets and capsules, and inspect the stability of preparation. METHODS: A Lichrosorb C 18 column was used. The mobile phase was acetonitrile∶10 mmol·L -1 sodium acetate triethylamine (pH5.5)(4∶96, v/v). The flow rate was 1.2 mL·min -1 . The detection wavelength was 286nm. The column temperature was set at room temperature. RESULTS: After optimization of HPLC conditions, no interference was observed. The limit of detection was 0.04 μg and the limit of quantitation was 0.12 μg. The linearity of the calibration curve was well correlated ( r =0.9998) within the range of 12.5 150 mg·L -1 . The recovery of standard addition was 99 % 101 %. Both the intra and inter RSD was below 3 %. CONCLUSION: The method is accurate, sensitive, and feasible.